Chronic DiseaseACTIVENCT06844786
SCORE! ACTIVE Trial
A study testing Physical activity program, Navigation and Health promotion in people with Chronic Disease and Childhood Obesity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Hamilton is a city with a growing newcomer population. Families who are new to Canada do not always have the same resources to access healthy active living (HAL) activities as compared to Canadian-born families. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Childhood Obesity
- What is being tested?
- Physical activity program, Navigation and Health promotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newcomer families (those who have been in Canada for 10 years or less) with at least 1 child aged 5 up to 11 (11.99 years) living in a Hamilton, Ontario.
- At least one parent/guardian born outside of Canada and residing in Canada ≤ 10 years.
- Families must be living in one of the designated neighbourhood clusters
Who cannot join
- Children participating in organized physical activity programs for 3 or more times per week
- Families with involvement with child protection services and/or foster care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Patricia Montague, MSc., 905-525-9140 ext. 21523, pmontag@mcmaster.ca
Gita Wahi, MD
About this study
Official title: SCORE! ACTIVE: Advancing Codesigned Health Promotion and Physical Activity Interventions to Improve Self-Efficacy and Health: A Stepped Wedge Cluster Randomized Trial
Hamilton is a city with a growing newcomer population. Families who are new to Canada do not always have the same resources to access healthy active living (HAL) activities as compared to Canadian-born families. The SCORE! ACTIVE trial will recruit newcomer families with young children in Hamilton and help provide them with access to HAL activities. Through this, the investigators want to see if newcomer children's perspectives of physical activity will change over time. They will also see if increasing newcomer children's access to these resources will promote an increase in HAL behaviours.
Read the detailed description
The investigators will conduct a pragmatic, stepped-wedge cluster randomized trial in 14 neighbourhoods to determine the impact of SCORE! ACTIVE trial on the primary outcome of PA self-efficacy among 5-11-year-old children. The SW-CRT involves the sequential transition of clusters, in this case neighbourhoods, from control to intervention conditions in a randomized order. In this case, the method is pragmatic because recruitment and initial baseline measures in each community will occur just before the initiation of the intervention. There have been methodological challenges noted with SW-CRT including identification and recruitment bias, within cluster bias, and secular trends. However, this design is ideal for the implementation of the SCORE! ACTIVE trial because for practical reasons, it is not possible to deliver the intervention to many clusters at the same time. The trial will be reported using CONSORT guidelines and extension of SW-CRT.
- Conditions
- Chronic Disease, Childhood Obesity
- Being tested
- Physical activity program, Navigation, Health promotion
- Medical subject headings
- Chronic Disease, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programOther
Also called SCORE! Club
SCORE! Club is offered twice a week for enrolled participants. Modules will include soccer, arts and health, Sportball, and nature-based activities.
NavigationOther
Also called SCORE! Navigator
Participants will have access to a navigator from the study team who will help them access resources relating to recreation and physical activity in their communities. For example, the navigator will help direct families with low income to the recreation assistance program if they are interested in such a service.
Health promotionOther
Also called Health promotion messaging
Health promotion messaging will be provided to participants via social media and other physical methods (i.e., flyers). Topics will include diet, sleep, physical activity, and other related items.
| Study group | Role | What they receive |
|---|---|---|
| SCORE! ACTIVE | Experimental | This is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention. Receives: Other: Physical activity program; Other: Navigation; Other: Health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
Using CSAPPA, a 19-item scale that measures how children feel about their physical activity skills and their likelihood of choosing physical activities, a change in children's physical activity self-efficacy will be measured at 6 months as the primary outcome.
Measured: Baseline to 6 months
Secondary outcomes (2)
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
Using CSAPPA, a change in children's physical activity self-efficacy will also be measured at 12 and 18 months as secondary outcomes.
Measured: 12 months from baseline; 18 months from baseline
Physical Activity & Sedentary Behavior Questionnaire
Changes in children's physical activity and sedentary behaviours will be measured using the Physical Activity \& Sedentary Behavior Questionnaire.
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Gita Wahi, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844786
- Sponsor's protocol ID
- 17739
- Acronym
- ACTIVE
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCORE! ACTIVE: Advancing Codesigned Health Promotion and Physical Activity Interventions to Improve Self-Efficacy and Health: A Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06844786
- Acronym / sponsor ID
- ACTIVE / 17739
- Conditions
- Chronic Disease, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hamilton is a city with a growing newcomer population. Families who are new to Canada do not always have the same resources to access healthy active living (HAL) activities as compared to Canadian-born families. The SCORE! ACTIVE trial will recruit newcomer families with young children in Hamilton and help provide them with access to HAL activities. Through this, the investigators want to see if newcomer children's perspectives of physical activity will change over time. They will also see if increasing newcomer children's access to these resources will promote an increase in HAL behaviours.
Detailed description
The investigators will conduct a pragmatic, stepped-wedge cluster randomized trial in 14 neighbourhoods to determine the impact of SCORE! ACTIVE trial on the primary outcome of PA self-efficacy among 5-11-year-old children. The SW-CRT involves the sequential transition of clusters, in this case neighbourhoods, from control to intervention conditions in a randomized order. In this case, the method is pragmatic because recruitment and initial baseline measures in each community will occur just before the initiation of the intervention. There have been methodological challenges noted with SW-CRT including identification and recruitment bias, within cluster bias, and secular trends. However, this design is ideal for the implementation of the SCORE! ACTIVE trial because for practical reasons, it is not possible to deliver the intervention to many clusters at the same time. The trial will be reported using CONSORT guidelines and extension of SW-CRT.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCORE! ACTIVE | Experimental | Other: Physical activity program, Other: Navigation, Other: Health promotionThis is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newcomer families (those who have been in Canada for 10 years or less) with at least 1 child aged 5 up to 11 (11.99 years) living in a Hamilton, Ontario.
- At least one parent/guardian born outside of Canada and residing in Canada ≤ 10 years.
- Families must be living in one of the designated neighbourhood clusters
Key exclusion criteria (2 listed)
- Children participating in organized physical activity programs for 3 or more times per week
- Families with involvement with child protection services and/or foster care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programAlso: SCORE! ClubSCORE! Club is offered twice a week for enrolled participants. Modules will include soccer, arts and health, Sportball, and nature-based activities. | Other | SCORE! ACTIVE |
| NavigationAlso: SCORE! NavigatorParticipants will have access to a navigator from the study team who will help them access resources relating to recreation and physical activity in their communities. For example, the navigator will help direct families with low income to the recreation assistance program if they are interested in such a service. | Other | SCORE! ACTIVE |
| Health promotionAlso: Health promotion messagingHealth promotion messaging will be provided to participants via social media and other physical methods (i.e., flyers). Topics will include diet, sleep, physical activity, and other related items. | Other | SCORE! ACTIVE |
Primary outcome
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
Time frame: Baseline to 6 months
Using CSAPPA, a 19-item scale that measures how children feel about their physical activity skills and their likelihood of choosing physical activities, a change in children's physical activity self-efficacy will be measured at 6 months as the primary outcome.
2 secondary outcomes
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
Time frame: 12 months from baseline; 18 months from baseline
Physical Activity & Sedentary Behavior Questionnaire
Time frame: Baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program, Navigation and Health promotion in people with Chronic Disease and Childhood Obesity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.